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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX; CORPATH GRX SYSTEM
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CORINDUS INC CORPATH GRX; CORPATH GRX SYSTEM Back to Search Results
Model Number 301
Device Problem Activation Problem (4042)
Patient Problem Chest Pain (1776)
Event Date 08/12/2021
Event Type  malfunction  
Event Description
After 1st stent placement an kb inflation (crux cords) proximal to the stent in 3rd seg.Of rca flow limiting dissection appeared.The attempt to robotically deliver the stent to cover it or balloon to do additional lesion preparation failed.Due to clinical condition (chest pain and ecg changes) decision was to switch to manual.After successful 2nd stent implantation and clinical stabilization 3rd stent and final ballooning done once more robotically.
 
Manufacturer Narrative
Incident reported to the manufacturer on 8/27/2021.There was no problem with the device during the procedure and the procedure was completed.The event was not device related and is a known risk of pci procedures.The device functioned as it was intended to and there was no problem with the way device was used.
 
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Brand Name
CORPATH GRX
Type of Device
CORPATH GRX SYSTEM
Manufacturer (Section D)
CORINDUS INC
309 waverly oaks road
waltham MA 02452
MDR Report Key12509398
MDR Text Key282295336
Report Number3007822508-2021-00003
Device Sequence Number1
Product Code DXX
UDI-Device Identifier00816280023017
UDI-Public00816280023017
Combination Product (y/n)N
PMA/PMN Number
K173806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number301
Device Catalogue Number301
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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